1. Field of the Invention
The present invention relates to a method for the production of a plant-based medicament which contains Iberis amara, Menthae piperitae folium, Matricariae flos, Carvi fructus, Mellissae folium, Angelicae radix, Liquiritiae radix, Cardui mariae fructus and Chelidonii herba in the form of alcoholic extracts, and a medicament produced by this method, and its use.
2. Background Art
Iberogast is a plant-based medicament (herbal combination preparation, phytopharmaceutical product), which is used for the treatment of functional dyspepsia and in gastrointestinal multitarget therapy. It has both a tonus-increasing effect in relaxed smooth musculature and also has a spasmolytic effect in paroxysmal states of the smooth musculature. The active pharmaceutical ingredients of this phytopharmaceutical product are preparations of fresh plants and herbal drugs, (dried plants or parts of plants) as ethanolic, liquid extracts. Iberogast contains extracts of Iberis amara (bitter candytuft), Menthae piperitae folium (peppermint leaves), Matricariae flos (chamomile flowers), Carvi fructus (caraway fruit), Melissae folium (lemon balm leaves), Angelicae radix (angelica root), Liquiritiae radix (liquorice root), Cardui mariae fructus (milk thistle fruit) and Chelidonii herba (celandine).
European Patent EP 0550 703 B1 already describes a plant-based medicament with a limited number of 6 extracts.
Iberogast itself, which comprises 9 extracts, is a medicament which has been well-established for years. The pharmaceutical quality of the extracts has a decisive influence on the effectiveness and harmlessness of herbal medicaments. In addition to complying with specifications of the initial drugs in accordance with the pharmacopeia, the reproducibility of the production processes (validation) is the essential prerequisite for the high standard as German and European phtyopharmaceutical product. Based on the new guidelines, which also apply to herbal medicaments in relation to the respective European regulations, there is an obligation to be consistent with the information regarding content which is declared for the respective medicament. Deviation from this information may only be ±5% of the declared content of the ingredients which determine effectiveness (lead substance, active marker or analytical marker substance).
It has proved to be problematic to obtain a constant effective substance content in the finished medicament Iberogast and to obtain a consistent, reproducible quality. Corresponding investigations with regard to the pharmaceutical development indicated precipitations/crystal formation in the extract of angelica root, which led to inhomogeneities in the production batch and consequently led to unacceptable fluctuations of the osthol content (lead substance). On the one hand, the recovery rate of the osthol content increased in the first weeks after the first analysis in clear-filtered solutions, and on the other hand the total content decreased in production batches in accordance with the sediment formation.